Last updated: April 11, 2024
Sponsor: University Hospital, Ghent
Overall Status: Active - Recruiting
Phase
N/A
Condition
In Vitro Fertilization
Treatment
EmbryoGlue®, Vitrolife
Conventional Transfer
Clinical Study ID
NCT04709796
BC-08429
Ages 18-40 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The trial only includes women with a clinical indication for ART with a history of RIFdefined as the absence of implantation after two consecutive cycles of IVF, ICSI orfrozen embryo replacement cycles where the cumulative number of transferred embryoswas no less than four for cleavage-stage embryos and no less than two for blastocysts,with all embryos being of good quality and of appropriate developmental stage. Furthermore, other specific 'RIF' investigations were performed and treated if necessary:
- Normal hysteroscopy
- Normal karyotype of both parents
- Coagulation screening (Antitrombine II deficiency, Factor VIII augmentation, APCresistance, Factor V + Factor II augmentation, Protein S and C deficiency anhomocysteine augmentation)
- Auto-immune screening (Lupus anticoagulant, Rheumatoid Factor, Anti-nuclearantibodies, Anti-cardiolipine antibodies and Glycoprotein-1-antibodies)
Exclusion
Exclusion Criteria:
- • Simultaneous participation in another clinical study
- Untreated and uncontrolled thyroid dysfunction
- Tumors of the ovary, breast, uterus, pituitary or hypothalamus
- Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause
- Ovarian cysts or enlarged ovaries
- Malformations of the reproductive organs
- Moderate or severe hepatic impairment
- Current use of oral contraceptives, anti-psychotics, anti-epileptics orchemotherapy
- Patients who undergo preimplantation genetic testing (PGT), fertilitypreservation or oocyte donation
- Couples needing TESE/MESA material
Study Design
Total Participants: 178
Treatment Group(s): 2
Primary Treatment: EmbryoGlue®, Vitrolife
Phase:
Study Start date:
March 03, 2021
Estimated Completion Date:
June 30, 2025
Connect with a study center
UZ Ghent
Ghent, 9000
BelgiumActive - Recruiting
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